BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 24886381 · Received April 15, 2026

    Report

    Report Number
    3005094123-2026-00175
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740162030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K62-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K62, 510K K983442. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE ELEVATED ARCHITECT TSH RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A 54-YEAR-OLD MALE WHO HAD UNDERGONE CORONARY ARTERY STENT IMPLANTATION. (CUSTOMER PROVIDED TSH REFERENCE RANGE: 0.35-4.94 UIU/ML). THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026 SID (B)(6) TSH RESULT = 3.1397 UIU/ML, NEW SAMPLE (B)(6) 2026 WITH TOSOH PLATFORM = 0.245. UIU/ML (TOSOH REFERENCE RANGE: 0.56-5.91 UIU/ML), (B)(6) 2026 SAMPLE REPEATED ON ARCHITECT WITH SID (B)(6) = 0.1993 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285285 ARCHITECT TSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 73531UD01 00380740162030

    Patients

    Seq Age Sex Outcome Treatment
    1